Gut Microbiota and Metabonomics (MBS)

Multi-center and Multi-omics Mechanism Research of Gut Microbiota and Metabonomics in Borrmann Type IV Gastric Cancer

To evaluate the correlation between gut microbiota and metabolites in Borrmann type IV gastric cancer; To find the effects of microflora and metabolites on target organs; To detect the mechanism of key flora and metabolite by in vitro and in vivo experiments; To construct models of gut microbiota and metabonomics by machine learning.

Study Overview

• Status: Recruiting
• Conditions: Stomach Neoplasms; Gut Microbiota; Metabolomics
• Intervention / Treatment: Procedure: Healthy control specimen collection; Procedure: Non-Borrmann IV patient specimen collection; Procedure: Borrmann IV patient specimen collection

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Kai Li, MD; Phone Number: 8613998245233; Email: cmu1h_likai@163.com

Study Locations

• China
  • Jiangsu
    • Changzhou, Jiangsu, China, 213001
      • Recruiting
      • The fourth People's Hospital of Changzhou
  • Liaoning
    • Chaoyang, Liaoning, China, 122099
      • Recruiting
      • Chaoyang Central Hospital
      • Contact: Shigang Guo
    • Fushun, Liaoning, China, 113012
      • Enrolling by invitation
      • The General Hospital of Fushun Mining Bureau
    • Jinzhou, Liaoning, China, 121012
      • Recruiting
      • First Hospital of Jinzhou Medical University
      • Contact: Yubin Wang
    • Shenyang, Liaoning, China, 110000
      • Active, not recruiting
      • The First Affiliated Hospital of China Medical University
  • Shandong
    • Ji'nan, Shandong, China, 250033
      • Enrolling by invitation
      • The Second Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy population will be selected from community samples. Non-Borrmann IV and Borrmann IV patients will be selected from Department of Oncology in hospitals.

Description

Inclusion Criteria:

1. Patients who sign informed consent.
2. Borrmann classification of gastric cancer is determined by more than 2 pathologists.
3. Patients with BMI 24-28.
4. Karnofsky (KPS) score >80.

Exclusion Criteria:

1. Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection.
2. Patients who complicate with other malignant tumors.
3. Patients who complicate with diabetes, hypertension, heart disease and infectious diseases.
4. Patients who complicate with inflammatory bowel disease or irritable bowel syndrome.
5. Patients with metastasis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy group; Healthy people in the community.	Procedure: Healthy control specimen collection; Collecting blood and feces from healthy population.
Non-Borrmann IV group; Patients with Borrmann types I, II and III gastric cancer.	Procedure: Non-Borrmann IV patient specimen collection; Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.
Borrmann IV group; Patients with Borrmann type IV gastric cancer.	Procedure: Borrmann IV patient specimen collection; Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' characteristics	To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.	1 day
Microbial community structure	To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.	1 day
Metabolite composition	To measure the metabolite profiles in participants' faecal samples and serum samples, involving Bile acids, short chain fatty acids, TMAO and related metabolites, amino acids, fatty acids, organic acids, flavonoids, plant hormones, neurotransmitters.	1 day
Microbes-metabolites correlations	To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.	1 day
Response of target organ	To find the effects of microflora and metabolites on target organ by transcriptome sequencing.	1 day

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University
• Collaborators: The Second Hospital of Shandong University; The First People's Hospital of Jingzhou; Liaoning Cancer Hospital & Institute; The General Hospital of Fushun Mining Bureau; The fourth People's Hospital of Changzhou
• Investigators: Principal Investigator: Kai Li, MD, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: Metabonomics

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No